NCT03928184

Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis

A 56-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize radiographs and patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.

Detailed description

SM04690-OA-11 was a phase 3, 56-week multicenter, randomized, double-blind, placebo-controlled, parallel group study investigating the safety, tolerability and efficacy of LOR 0.07 mg (compared with PBO) injected into the target knee joint of moderately to severely symptomatic knee OA subjects. Patient-reported outcomes included Pain Numeric Rating Scale (NRS) \[0-10\], Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Patient Global Assessment (PGA) of knee osteoarthritis. Joint space as measured by a positioner-assisted posterior-anterior x-ray was the radiographic outcome. The primary efficacy endpoint was change from baseline in target knee Pain NRS at Week 12. Secondary endpoints included change at Week 12 in WOMAC Function and PGA, as well as change in joint space at Week 52.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Lorecivivint	Healthcare professional-administered intra-articular injection; performed on Day 1
DRUG	Placebo	Healthcare professional-administered intra-articular injection; performed on Day 1

Timeline

• Start date: 2019-05-17
• Primary completion: 2021-08-20
• Completion: 2021-08-20
• First posted: 2019-04-26
• Last updated: 2026-02-13
• Results posted: 2026-02-13

Locations

99 sites across 1 country: United States

Regulatory

• FDA-regulated drug study